Use of Blood Ketone Meters to Improve Ambulance Hyperglycaemia Care

Diabetic Ketoacidosis Clinical Trial

— KARMA2  

Official title:

Use of Capillary Blood Ketone Meters to Improve Ambulance Service Care of Hyperglycaemic Patients: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04940897
• Other study ID #: KARMA2
• Status: Completed
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: February 23, 2023

Study information

• Verified date: February 2023
• Source: East of England Ambulance Service NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this KARMA2 feasibility study the investigators are testing whether ambulance staff can reliably and safely identify patients at high risk of diabetic ketoacidosis using blood ketone meters and start fluid (saline) therapy before arriving at hospital. The investigators aim to include 800 patients in this stepped wedge control study and the results will help decide if a larger study is warranted.

Description:

Diabetic ketoacidosis (DKA) is a potentially life-threatening condition which requires immediate treatment. National Health Service (NHS) hospital guidelines recommend immediate fluid (saline) therapy. Delays in diagnosis and treatment are known to be associated with health complications and death.

There is an opportunity to involve ambulance crews to improve DKA identification and treatment times; however, currently ambulance staff do not have access to ketone testing, and fluids are recommended only when it is thought a patient is critically unwell.

In this KARMA2 feasibility study the investigators are testing whether ambulance staff can reliably and safely identify patients at high risk of DKA using blood ketone meters and start fluid (saline) therapy before arriving at hospital.

During an 8-month period (4-month control followed by 4-month intervention), 120 ambulance clinicians from the East of England Ambulance Service NHS Trust will receive training to consent 400 patients with hyperglycaemia and unwell patients with diabetes to the control group receiving usual care, followed by determining the presence of ketones using capillary blood testing from a further 400 consenting patients with hyperglycaemia and unwell patients with diabetes. Subsequent patient care will depend on the ketone value obtained: high-risk DKA patients will receive fluid therapy.

Twenty ambulance and hospital clinicians will be invited to an online interview to share views of DKA care and the impact of ambulance blood ketone meters. The results will help the investigators decide if a larger study would be a good idea.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: February 23, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years or more

• Attended by study clinician

• Informed or Proxy consent to participate

• Blood glucose level greater than 11mmol/L or unwell with history of diabetes

• If required will be transported to partner hospital

Exclusion Criteria:

• Failure to meet inclusion criteria

• Previously recruited to study

Related Conditions & MeSH terms

• Diabetic Ketoacidosis
• Ketosis

Intervention

Other:
• Use of CareSens ketone meter
Use of CareSens ketone meter to identify blood ketone levels and delivery of fluid therapy to those patients at high risk of DKA

Locations

Country	Name	City	State
United Kingdom	East of England Ambulance Service NHS Trust	Melbourn	Cambs

Sponsors (1)

Lead Sponsor	Collaborator
East of England Ambulance Service NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure incidence of hyperglycaemia in study population	Frequency count of capillary blood glucose level greater than 11mmol/L	18 months
Primary	Measure incidence of diabetic ketoacidosis (DKA) in study population	Frequency count of capillary blood ketone level equal to or greater than 3mmol/L	18 months
Primary	Completeness of data capture by study clinicians	Progression criteria requires full record completion for a minimum of 70 percent of participants	18 months
Primary	Measure incidence of adverse events	Progression criteria requires adverse event rate to be less than 1 percent of participants	Maximum 18 months